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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX1502 in Normal Healthy Volunteers

PrimarySAD: - To evaluate the safety and tolerability of single ascending doses of ANX1502 in healthy participants.MAD: - To evaluate the safety and tolerability of multiple ascending doses of ANX1502 in healthy participants.SecondarySAD: - To…

A randomized, double-blind, placebo-controlled study of the tolerability, pharmacokinetics and pharmacodynamics of ascending single and repeated subcutaneous doses of SAR444336 in healthy adult participants

Primary objective- To assess the tolerability and safety of SAR444336 after single and repeated ascending subcutaneous doses Secondary objectives- To assess the PK parameters of SAR444336 after single ascending subcutaneous doses (Part 1)- To assess…

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

This study has been transitioned to CTIS with ID 2023-508645-40-00 check the CTIS register for the current data. Parts A and B:To evaluate the efficacy of efgartigimod PH20 SC on achieving sustained remission in the treatment of participants with…

CHAMP: Children with Arthritis: Monotherapy or Polytherapy. A multicentre, single-blinded, randomized treat to target, one-year follow-up clinical trial in patients with recent onset Juvenile Idiopathic Arthritis (JIA).

To study whether polytherapy (methotrexate plus sulfasalazine plus hydroxychloroquine) results in more patients with inactive disease and therefore less patients who need treatment with a TNF inhibitor after 6 months of treatment compared to primary…

A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib (ABT 494) to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)

Main objective:1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)

Primary Efficacy Objective (Blinded Treatment Period)• To demonstrate the efficacy of rilzabrutinib versus placebo in participants with refractory/relapsed ITP, based on the durability of platelet response during the last12 weeks of the 24-week…

Postponing cognitive decline and preventing early unemployment in patients with multiple sclerosis - strengthening the brain and mind (part of the Don't be late! study)

(1) To compare the efficacy of two innovative preventative interventions with a control intervention in improving quality of life, cognition, work participation and productivity, brain plasticity and resilience, (2) to gain insight into the…

REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in newly diagnosed PolyMyalgia Rheumatica

This study has been transitioned to CTIS with ID 2024-513544-28-00 check the CTIS register for the current data. The main objective is to study the efficacy of treatment with RTX in patients with newly diagnosed PMR compared to placebo.

Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents versus Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus Global (ABILITY Diabetes Global)

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus/Abluminus DES+ sirolimus-eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES).…

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

• To assess the efficacy of rozanolixizumab as measured by seizure freedom• To assess the efficacy of ozanolixizumab as measured by change in cognitive function• To assess the efficacy of ozanolixizumab as measured by use of rescue medication• To…

Development of Artificial inTelligence based digitaL monitoring of rheumAtoid arthritis patientS (ATLAS)

Primary Objective: To evaluate the *Triple Aim* performance of Care Pathway Technology for RA: - Evaluate and compare predefined RA health outcomes; Disease activity measured by DAS 28 joint score at baseline, month 12; RAPID3, HAQ-DI at baseline…

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in patients with gMG on stable background therapy. In addition, the study will assess the long-term safety and efficacy of…

ANIfrolumab treatment for 24 weeks in patients with primary Sjögren*s syndrome - Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial (ANISE-II)

This study has been transitioned to CTIS with ID 2024-516770-29-00 check the CTIS register for the current data. The objective of this study is to evaluate the clinical efficacy, biological effects and safety of anifrolumab treatment in pSS.

A randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate safety, PK and the immunosuppressive effects of p38 MAPK inhibitor POLB 001 on the intradermal and intravenous LPS challenge response in healthy volunteers.

• To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers• To evaluate the effect of POLB 001 on inflammatory responses following an intravenous LPS challenge in healthy volunteers

An alternating panel, single ascending dose trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, relative bioavailability, and food effect of orally administered AS-1763 in healthy subjects

In this study we will investigate how safe the new compound AS-1763 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent AS-1763 is absorbed, transported, and eliminated from the…

A DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWING STEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS

Primary* To evaluate the effect of RO7049665 on time to relapse following forced CCS tapering as measured by the hazard ratio between 7.5 mg RO7049665 and placebo.Secondary* To assess changes in alanine aminotransferase (ALT), aspartate…

A phase 1, first-in-human, 2-part, randomized, double-blind, placebo
controlled, single ascending dose and sequential, open-label, multiple
ascending dose study to evaluate the safety, tolerability,
pharmacodynamics, and pharmacokinetics of VIS171 in healthy
participants and participants with autoimmune disease(s)

The purpose of this first-in-human (FIH) study is to assess the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (single ascending dose [SAD] - Part A) as well as in…

A Phase 1 Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Nipocalimab in Healthy Male and Female Participants.

In this study we will investigate how safe the new compound nipocalimab is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent nipocalimab is absorbed, transported, and eliminated…

A Phase 1, Randomized, Single-Center Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of R948835 in Healthy Subjects

Primary objectives:Part A: To investigate the safety and tolerability of single ascending oral doses of R835 in healthy subjects.Part B:To investigate the safety and tolerability of multiple ascending oral doses of R835 in healthy subjects.Part C:…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO)

Primary Objective:* To evaluate the effect of every-other-week subcutaneous (SC) administration of XmAb5871 on the time to IgG4-related disease (IgG4-RD) disease flare following an initial course of corticosteroid therapy in subjects with active…